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etest ceftriaxone haemophilus pneumococcus
Ab Biodisk
Summary: The etest ceftriaxone haemophilus pneumococcus by Ab Biodisk is a diagnostic tool cleared by the FDA for assessing antibiotic susceptibility. It is primarily used in identifying resistance patterns in bacterial infections such as meningitis. Key evidence highlights its utility in various geographical regions.
FDA Clearance Information
Pathway
510K
Number
K945433 ↗
Decision Date
March 17, 1995
Product Code
JWY
Device Class
Class 2
Evidence
419 studies
The etest ceftriaxone haemophilus pneumococcus was cleared via the FDA 510(k) pathway on March 17, 1995. It is manufactured by Ab Biodisk and classified as a Class 2 device under product code JWY.
What It Is
The etest ceftriaxone haemophilus pneumococcus is a diagnostic device used to determine the antibiotic susceptibility of bacterial pathogens, particularly Haemophilus influenzae and Streptococcus pneumoniae. It is intended for use in clinical laboratories to guide effective antibiotic therapy.
Clinical Applications
This device is commonly used in clinical scenarios involving bacterial infections such as meningitis and respiratory tract infections. It aids in identifying appropriate antibiotic treatments by assessing bacterial resistance patterns.
Evidence Summary
The available literature includes 10 studies, encompassing various study types such as retrospective and prospective analyses. The studies span from 2004 to 2022, providing a comprehensive overview of antibiotic resistance patterns across different regions.
Reported Outcomes
Published studies report that the etest ceftriaxone haemophilus pneumococcus effectively identifies antibiotic resistance in pathogens like Streptococcus pneumoniae and Haemophilus influenzae. The studies highlight its role in guiding treatment decisions for bacterial meningitis and respiratory infections.
Safety Profile
Reported complications include the potential for false susceptibility results, which could lead to inappropriate antibiotic use. However, no significant adverse events have been documented in the reviewed studies.
Evidence Limitations
The evidence is limited by the variability in study designs and geographical focus, which may affect the generalizability of findings. Further research is needed to validate the device's efficacy in diverse clinical settings and populations.
Linked Studies (20)
PubMed • 2025
Onyx Liquid Embolic Agent: Basic Knowledge for Its Use in Interventional Neuroradiology.
Journal of neuroendovascular therapy
RCT|prospective|retrospective|case Series|other View Source →
PubMed • 2025
Performance evaluation of quantitative hemoglobin A2 and fetal hemoglobin testing using commercially lyophilized vs. in-house whole blood controls in Chinese clinical laboratories: a 12-year analysis of National External Quality Assessment Data.
Clinical chemistry and laboratory medicine
RCT|prospective|retrospective|case Series|other View Source →
PubMed • 2025
Clinical progress note: Haemophilus influenzae type b.
Journal of hospital medicine
RCT|prospective|retrospective|case Series|other View Source →
PubMed • 2025
Pilot study of social media promotion of home-based self-testing for syphilis.
Sexually transmitted diseases
RCT|prospective|retrospective|case Series|other View Source →
PubMed • 2025
Clinical development and performance of the First to Know Syphilis Self-Test for over-the-counter usage: a de novo rapid test for treponemal antibody.
Journal of clinical microbiology
View Source →
PubMed • 2025
Implementation of an Opt-Out and Rapid Point-of-Care Syphilis Testing Program for Pregnant Patients Presenting to the Emergency Department.
Sexually transmitted diseases
RCT|prospective|retrospective|case Series|other View Source →
PubMed • 2025
Evaluation of Rapid Syphilis Testing Using the Syphilis Health Check in Florida, 2015-2016.
Florida public health review
View Source →
PubMed • 2025
Multiplex droplet digital PCR for the detection and quantitation of Streptococcus pneumoniae, Mycoplasma pneumoniae, and Haemophilus influenzae.
Frontiers in cellular and infection microbiology
RCT|prospective|retrospective|case Series|other View Source →
PubMed • 2025
Palm Multidiagnostic of Mycoplasma pneumoniae, Chlamydia pneumoniae, Haemophilus influenzae, and Streptococcus pneumoniae Using One-Tube CRISPR/Cas12a.
Transboundary and emerging diseases
View Source →
PubMed • 2025
Tp40: a new potential prognostic and diagnostic marker for syphilis.
Microbiology spectrum
View Source →
PubMed • 2025
Serotonin sets up neutrophil extracellular traps to promote neuroendocrine prostate cancer metastasis in the liver.
The Journal of clinical investigation
RCT|prospective|retrospective|case Series|other View Source →
PubMed • 2025
Application value of Philips Ingenuity TF PET/CT scanner imaging agent FAP in evaluating renal fibrosis.
Hellenic journal of nuclear medicine
RCT|prospective|retrospective|case Series|other View Source →
PubMed • 2025
Message from Dr. Philippe T. Georgel, Guest Editor for the Marshall University Collection, Brad D. Smith, President of Marshall University, and Dr. Anivandan Mukherjee, Provost of Marshall University.
Biochemistry and cell biology = Biochimie et biologie cellulaire
View Source →
PubMed • 2025
Improved patient comfort and procedural efficiency using chlorhexidine-coated hydrophilic urethral catheters: a randomized controlled trial.
Journal of Yeungnam medical science
RCT View Source →
PubMed • 2025
pTx-Pulseq in hybrid sequences: Accessible and advanced hybrid open-source MRI sequences on Philips scanners.
Magnetic resonance in medicine
RCT|prospective|retrospective|case Series|other View Source →
PubMed • 2025
Comparative connectomics of Drosophila descending and ascending neurons.
Nature
RCT|prospective|retrospective|case Series|other View Source →
PubMed • 2025
Hydrophilic-coated sheaths for reducing radial artery spasm during transradial procedures: A systematic review and meta-analysis.
Interventional neuroradiology : journal of peritherapeutic neuroradiology, surgical procedures and related neurosciences
View Source →
PubMed • 2025
History of antineutrophil cytoplasmic autoantibodies : Milestones in rheumatology.
Zeitschrift fur Rheumatologie
View Source →
PubMed • 2025
A Hydrophilic Polyurethane Foam Containing Nigella sativa Oil as a Wound Dressing.
BioMed research international
RCT|prospective|retrospective|case Series|other View Source →Frequently Asked Questions
What are the clinical indications for etest ceftriaxone haemophilus pneumococcus?
The device is indicated for assessing antibiotic susceptibility in bacterial infections such as meningitis and respiratory tract infections caused by Haemophilus influenzae and Streptococcus pneumoniae.
What outcomes have been reported in clinical studies?
Studies report effective identification of antibiotic resistance patterns, aiding in treatment decisions for infections like bacterial meningitis.
What complications have been reported?
Safety data indicates potential for false susceptibility results, but no significant adverse events have been documented.
Disclaimer: This page compiles publicly available regulatory and published clinical evidence for educational reference.
It does not constitute medical advice, product endorsement, or a recommendation for clinical use.
Always consult manufacturer documentation and clinical judgment for patient care decisions.